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FDA approves first marijuana-derived drug- and it may spark DEA rescheduling

26 June 2018
FDA approves first marijuana-derived drug- and it may spark DEA rescheduling

GW Pharmaceuticals Plc's epilepsy treatment on Monday secured an approval from the U.S. Food and Drug Administration, becoming the first cannabis-based drug to be approved in the country. A study at the end of previous year found that almost 70 percent of CBD products sold online were mislabeled.

The Drug Enforcement Administration must reclassify cannabidiol before GW Pharma can market Epidiolex.

Nasdaq-listed GW Pharmaceuticals, which grows its own marijuana plants in glass houses in Britain, hopes the drug will be approved in the United Kingdom next year.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies" said FDA Commissioner Scott Gottlieb.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.

"These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care", Gover said. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders". Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical objective (heroin, LSD, and ecstasy are also Schedule I drugs).

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

CBD is the common abbreviation for cannabidiol, a chemical derived from cannabis.

The U.S. approval for Epidiolex was largely expected after an FDA advisory panel endorsed it with a 13-0 vote in April.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy.

While supporters of legalizing marijuana say the decision is a step in the right direction, businesses reliant on the plant must contend with the federal government's ban on its use in all forms. That decision is expected within 90 days.

The medication, tested in three randomized, placebo-controlled trials with more than 500 patients, was effective in reducing seizures, the FDA said. "There's no time line or clock that starts ticking on us".